The Impact of off-Label, Compassionate, and Unlicensed Use on Health Care Laws in Preselected Countries

In times of situational therapeutic impasse, health care professionals (HCPs) are under pressure to conduct off-label, unlicensed and compassionate drug use--generally summarized under the term non-licensed drug use (NDU). Liability, contractual and penal risks pose a problem when treating a patient in a non-licensed way. There is a knowledge gap about institutional and governmental methods to resolve these problems. Different countries have developed strategies to manage NDU. Vanessa...
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In times of situational therapeutic impasse, health care professionals (HCPs) are under pressure to conduct off-label, unlicensed and compassionate drug use--generally summarized under the term non-licensed drug use (NDU). Liability, contractual and penal risks pose a problem when treating a patient in a non-licensed way. There is a knowledge gap about institutional and governmental methods to resolve these problems. Different countries have developed strategies to manage NDU. Vanessa Platé gives a comprehensive overview of practices Canada, the U.S., the U.K., Japan, France, Germany, Switzerland, Austria, and the transnational E.U. A must-read for everyone interested in the discussion on how to administer the best treatment, especially regarding early access to yet unapproved treatments.